跳至主要内容
临床试验/NCT03786679
NCT03786679招募中不适用

Non-operative Treatment in Sweden of Proximal Humeral Fratures, a Randomised Multicenter Trial.

Lars Adolfsson2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2019年2月25日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
400
试验地点
2
主要终点
Union of fracture

研究概览

简要总结

Proximal humeral fractures are common especially in the elderly population. The majority of these fractures are minimally displaced and may be treated non-operatively. There is however a controversy about which fractures that need surgery and randomised trials have not been able to show a clinically important advantage in patient reported outcome measures for those operated. The trend is therefore that also displaced and comminute fractures are treated non-operatively. There is however very little scientific support for how the non-operative treatment should be designed and performed. Therefore this prospective multicenter study is aiming at investigating the benefit of a four week immobilisation orthosis as compared to early range of motion exercises for those patients not assigned for surgery one week after the trauma.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

The assessors are not involved in the treatment and the radiological assessment of images will be assessed with anonymyized images.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • A proximal humeral fracture verified on radiology no older than 7-10 days.

排除标准

  • Surgically treated proximal humeral fracture
  • Fracture only involving the greater tuberosity
  • Previous surgery in the fractured shoulder
  • Ongoing malignancy in the fractured shoulder
  • Neurologic disease
  • Radiating pain from the neck in the affected arm
  • Associated vascular or nerve injuries
  • Alcohol abuse
  • Unwilling to participate in the trial

结局指标

主要结局

Union of fracture

时间窗: Followed 12 months

recording of fracture union on radiological images

次要结局

  • Quick DASH(12 months)
  • Oxford shoulder score(12 months)
  • Numerical pain reporting scale(12 months)
  • Global assessment of improvement(12 months)
  • Shoulder range of motion(12 months)

研究者

发起方
Lars Adolfsson
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Lars Adolfsson

Professor

Linkoeping University

研究点 (2)

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